Every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this growing universe of data.
This role reports to the Head of CDM Process.
The CDM Knowledge Manager will be accountable for capability, learning and knowledge management activities related to the delivery of CDGM services and the adoption of TMF (Trial Master Files) and good documentation practices across the business.
Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.
Key responsibilities:
• Accountable for knowledge management activities related to clinical document management processes, adoption of TMF and good documentation practices across the business.
• Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis
• Develop and implement effective, fit for purpose capability development, learning and knowledge management deliverables to users of TMF and CDGM services across the business.
• Partner with key collaborators across the business to understand learning and knowledge management needs and proactively identify/implement solutions to meet those needs.
• Build and handle metrics/KPIs and dashboards relating to CDGM learning, capability and knowledge management activities and facilitate discussions with CDGM LT and others relating to trends and issues.
• Partner with service providers and internal collaborators to ensure 3rd party partners are aware of and delivering their services aligned with CDGM capability, learning and knowledge management requirements.
• Partner with learning, capability and knowledge management groups across Novartis to ensure CDGM are aligned with wider efforts, and to keep aware and leverage standard methodologies and new developments.
• Serve as Subject Matter Expert on TMF learning, formal and informal processes and tracking tools relating to learning, capability development and knowledge management.
• Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across customer groups.
• Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive work environment that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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